Hypertension Control Program in Argentina (HCPIA)
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|ClinicalTrials.gov Identifier: NCT01834131|
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Comprehensive Intervention||Not Applicable|
Background: Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease and premature death have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low and middle income countries.
Objectives: To test whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive patients and their families in Argentina
Design: Cluster randomized trial
Study Participants: 1,890 study participants from 18 primary care clinics within a public primary care network in Argentina will be recruited. Patients with hypertension from the participating clinics, their spouses, and their adult hypertensive family members will be enrolled.
Intervention: Nine clinics with approximately 945 participants will be randomly assigned to the comprehensive intervention group and 9 clinics with similar participants to the usual care group. The comprehensive intervention, including health care provider education, a home-based intervention among patients and their families (lifestyle modification and home blood pressure [BP] monitoring) delivered by community health workers, and a mobile health intervention, will last for 18 months.
Outcomes: BP and other indicators will be measured at baseline and months 6, 12, and 18 during follow-up using standard methods. The primary outcome is a net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants. The secondary outcomes are the proportion of hypertensive patients with adequate BP control (BP<140/90 mmHg), cost-effectiveness of hypertension control, and net BP changes in normotensive participants.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1954 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comprehensive Approach for Hypertension Prevention and Control in Argentina|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
No Intervention: Usual Care
Clinics assigned to usual care will not receive any of the intervention components. Physicians in these clinics will continue to treat patients using their usual methods. Participants from these clinics will not receive community health worker visits or the mobile health intervention
Experimental: Comprehensive Intervention
Behavioral: Comprehensive Intervention
The comprehensive intervention includes physician education, a community health worker home intervention and a mobile health intervention. Please see Arm Description for details.
- Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants. [ Time Frame: Baseline and 18 months ]Three BP measurements will be obtained at each data collection visit by study nurses who are masked to clinic assignment. BP will be measured according to a standard protocol recommended by the American Heart Association. The average of the three measurements will be used to compare the change over 18 months between the intervention and control groups.
- Proportion of hypertension control (BP<140/90 mmHg) among hypertensive patients [ Time Frame: Baseline and 18 months ]The proportion of hypertensives with blood pressure control (defined as (BP<140/90 mmHg or < 130/80 mmHg if patient has diabetes of CKD) will be compared between the intervention and control group.
- Self-reported medication adherence among hypertensive patients [ Time Frame: Baseline and 18 months ]The Morisky scale questionnaire will be administered at baseline and 18 months of follow-up to compare medication adherence between the intervention and control groups.
- Cost-effectiveness of the intervention [ Time Frame: Baseline and 18 Months ]All resources involved in conducting this comprehensive intervention program, as well as all patient-level costs, will be documented. Primary incremental cost effectiveness ratio (ICER) measure will be cost per mmHg of change in SBP and DBP.
- Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among normotensive study participants [ Time Frame: Baseline and 18 months ]Three BP measurements will be obtained at each data collection visit by study nurses who are masked to clinic assignment. BP will be measured according to a standard protocol recommended by the American Heart Association. The average of the three measurements will be used to compare the change over 18 months between the intervention and control groups among normotensives.
- Net change in body weight and waist circumference from baseline to 18 months [ Time Frame: Baseline and 18 months ]Study nurses will take anthropometric measurements on individuals in light clothing without shoes using a standard protocol.
- Intensity of treatment [ Time Frame: Baseline and 18 months ]Intensification (titration and/or addition) of antihypertensive medications,compared between the intervention and control groups after 18 months of follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834131
|Institute for Clinical Effectiveness and Health Policy|
|Buenos Aires, Argentina, C1414CPV|
|Principal Investigator:||Jiang He, MD, PhD||Tulane University Health Sciences Center|